美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=ANDA207743"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
0904-7111-61 0904-7111 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 20241130 ANDA ANDA207743 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 300 mg/1 100 BLISTER PACK in 1 CARTON (0904-7111-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
0904-7110-61 0904-7110 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 20241231 ANDA ANDA207743 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 200 mg/1 100 BLISTER PACK in 1 CARTON (0904-7110-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
0904-7109-61 0904-7109 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 20241231 ANDA ANDA207743 Major Pharmaceuticals LABETALOL HYDROCHLORIDE 100 mg/1 100 BLISTER PACK in 1 CARTON (0904-7109-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
55154-2339-0 55154-2339 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 20241231 ANDA ANDA207743 Cardinal Health 107, LLC LABETALOL HYDROCHLORIDE 200 mg/1 10 BLISTER PACK in 1 BAG (55154-2339-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
55154-8192-0 55154-8192 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190716 N/A ANDA ANDA207743 Cardinal Health 107, LLC LABETALOL HYDROCHLORIDE 100 mg/1 10 BLISTER PACK in 1 BAG (55154-8192-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
67046-1042-3 67046-1042 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20241108 N/A ANDA ANDA207743 Coupler LLC LABETALOL HYDROCHLORIDE 100 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1042-3)
68001-381-03 68001-381 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 100 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (68001-381-03)
68001-383-00 68001-383 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 300 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68001-383-00)
68001-383-03 68001-383 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 300 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (68001-383-03)
68001-382-00 68001-382 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 200 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68001-382-00)
68001-382-03 68001-382 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 200 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (68001-382-03)
68001-381-00 68001-381 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20190218 N/A ANDA ANDA207743 BluePoint Laboratories Inc. LABETALOL HYDROCHLORIDE 100 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68001-381-00)
68382-798-01 68382-798 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 100 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68382-798-01)
68382-799-01 68382-799 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 200 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68382-799-01)
68382-799-05 68382-799 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 200 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (68382-799-05)
68382-799-06 68382-799 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 200 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68382-799-06)
68382-799-16 68382-799 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 200 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68382-799-16)
68382-800-01 68382-800 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 300 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68382-800-01)
68382-800-05 68382-800 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 300 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (68382-800-05)
68382-800-06 68382-800 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20171205 N/A ANDA ANDA207743 Zydus Pharmaceuticals USA Inc. LABETALOL HYDROCHLORIDE 300 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68382-800-06)
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